WASHINGTON
– Senate Finance Committee Chairman Chuck Grassley (R-Iowa) submitted policy
suggestions to the Centers for Medicare and Medicaid Services (CMS) as the
agency finalizes proposed federal guidance clarifying how CMS and state
surveyors will evaluate the use of shared space, shared staff, and contracted
services by hospitals that are co-located with other hospitals and health care
providers under the Medicare program.

Hospitals
located in rural and frontier communities often enter into special co-location
or shared space arrangements in order to furnish the specific medical services
that meet the unique needs of their patient populations. Allowing rural
hospitals to lease space once a month to a surgeon or an endocrinologist
benefits Medicare patients by increasing their access to specialized medical
care as close to home as is possible. Due to inconsistent statements made by
CMS, however, some hospitals scaled back, or completely dismantled, their
co-location agreements. As a result, Chairman Grassley urged CMS to release
guidance that updates and modernizes its existing co-location policy. The
agency issued its draft guidance, seeking public feedback, on May 3, 2019.

“By
better defining and clarifying allowable co-location and shared space arrangements,
CMS is giving hospitals and health systems much needed flexibility and
operational certainty when they choose to partner with other health care
entities,” Grassley wrote. “…however, I do believe increased specificity
and flexibility…is necessary to ensure hospitals understand exactly what
co-location activities are allowed and those that are not.”

In a letter to CMS Administrator Seema Verma, Grassley pressed
for the clarification of key technical terms referenced in the proposed
guidance in order to better reflect policy intent, reduce provider confusion,
ensure provider participation, and enable successful implementation of the new
requirements. The senator encouraged CMS to consider under what appropriate
circumstances co-located facilities might be allowed to coordinate more
streamlined patient travel plans that keep patients safe but also reduce
administrative burden. Grassley also sought clarity on the provision of
emergency services as well as which specific medical staff would be allowed to
share time or “float” between co-located facilities.

Attention: [QSO-19-13-Hospital]
Draft Guidance for Hospital Co-Location with Other Hospitals or Healthcare
Facilities.

Dear Administrator Verma:

Co-location and shared space arrangements under the Medicare
program allow hospitals to share space, services and staff with other
providers. Hospitals located in rural and frontier communities often choose to
enter into these special arrangements with other hospitals, hospital systems,
or providers of care in order to offer a broader range of medical services that
best meets the unique needs of their patient populations. For example, a rural
hospital may lease space once a month to medical specialists from out of town,
such as an orthopaedic surgeon, a cardiologist, an endocrinologist, or a
behavioral health care provider. These types of co-location and shared space
arrangements benefit Medicare patients living in rural and frontier areas by
increasing access to specialized medical care, improving care coordination
services, and offering more convenient care options as close to home as
possible.

Hospitals that want to enter into a co-location or shared space
arrangement with another hospital or provider typically work with either a
state health department or a contracted Centers for Medicare and Medicaid
Services (CMS) agency, accreditor or regional office to make sure that the new
arrangement meets Medicare requirements. In May of 2015, however, inconsistent
statements made by CMS led to a lack of clarity for hospitals as to how they
can enter into co-location and shared space arrangements while maintaining
compliance with the conditions of participation (CoPs) for hospitals under the
Medicare program under part 482 of title 42, Code of Federal Regulations (CFR)
or any successor regulations.

Currently hospitals do not have a complete understanding of what
standards constitute separateness, when separate entrances may be required,
which types of services may be shared, and how adequate levels of public
awareness are reached when one provider leases space to another provider. One
thing is clear: rural and frontier
hospitals face unique health care delivery challenges that co-location and
shared space arrangements can help them overcome. However, out of an abundance
of concern, and in the absence of clear direction, some hospitals have begun to
unwind or completely dismantle their co-location or shared space arrangements.

On May 3, 2019, CMS released draft guidance seeking to clarify
how the agency and state surveyors will evaluate the use of shared space,
shared staff, and contracted services by hospitals co-located with another
hospital or health care entity.[1]
The draft guidance is welcome and necessary. Having long pressed CMS to
modernize and improve its existing co-location policy, I applaud the
Administration for taking meaningful action to stem hospital and provider
confusion surrounding this matter.

The CMS draft guidance represents a significant update to
previous sub-regulatory interpretations which may have unintentionally resulted
in Medicare beneficiaries, especially those patients living in rural and
frontier areas, having difficulty accessing needed medical care. It seeks to
clarify compliance, streamline the survey process, prioritize patient care,
ensure patient safety and mandate facility accountability – all without
increasing provider regulatory burden. By better defining and clarifying
allowable co-location and shared space arrangements, CMS is giving hospitals
and health systems much needed flexibility and operational certainty when they
choose to partner with other health care entities.

During my substantive review of the draft guidance, however, I
do believe increased specificity and flexibility in four key areas is necessary
to ensure hospitals understand exactly what co-location activities are allowed
and those that are not. Clarification is critical to enable successful
implementation of any proposed regulatory updates. I respectfully commend the
following policy concerns to your attention, which I believe must be addressed
prior to CMS finalizing its guidance.

Definitions

CMS incorporates several technical terms into its draft
guidance, but does not explain them. CMS should insert a definitions section
into a final guidance document. Doing so would improve provider understanding
of its policy proposals. Examples include the following:

Health Care
Entity.
It is unclear what constitutes a health care entity. CMS should outline
what types of hospital and physician providers meet this criteria.

Staffing
Contracts.
Health care providers enter into various contractual agreements in order
to furnish medical care or administrative services in co-located
facilities. CMS should also define this term to prevent provider
confusion.

Duty Hours. Hospitals
and providers independently decide their staff work schedules and shift
lengths. In fact, certain health care professionals work on specialized units
(such as surgery, intensive care, or dialysis) which require them to be on
call after a regularly scheduled shift ends. Due to varying work hours,
CMS should define the term “shift” to clarify what shared staff floating
between co-located entities is permitted and what is not.

Emergency
Services.
Hospitals provide swift medical attention to any individual experiencing
an emergency no matter where it may take place within the facility. This
often requires initial assessment, preliminary treatment, resuscitation,
stabilization, and transfer to a co-located health care facility for
additional care services. The draft guidance does not define either the
term “emergency services” or the term “emergency department”. CMS should
clarify its terminology so that hospitals and providers understand the
specific situations that would trigger Emergency Medical Treatment and
Labor Act (EMTALA) obligations.

Distinct Space and Shared Space Patient Travel

Medicare evaluates each participating hospital to determine its
compliance with the program’s CoPs. Co-located hospitals are expected to
maintain control over both distinct spaces and shared spaces of operation at
all times. Distinct spaces are non-public clinical settings designated to
furnish medical care. They are necessary in order to protect patient safety,
confidentiality, and security. Shared spaces, such as main building entrances,
lobbies, elevators, public restrooms, and staff lounges, are common areas and
paths of travel utilized by both co-located facilities.

On pages 1-2 of the draft guidance, CMS states that patient
travel through shared clinical spaces may pose an infection control risk. I
fully support the agency’s primary mission to protect patient safety, care
quality, and confidentiality. That said, I have heard from multiple
stakeholders concerned that there are certain patients who might be better
served if allowed to travel through appropriate clinical shared spaces in order
to receive needed services. Let me be clear:
I do not support unsupervised, general population travel through
clinical areas of a co-located hospital. I would ask the agency, however, to
carefully consider if there are any appropriate circumstances in which co-located
facilities should be allowed to coordinate with each other in implementing a
streamlined patient travel plan that reduces administrative burden while
ensuring complete facility compliance with Medicare’s CoPs in the clinical
common areas outlined in the draft guidance.

Staffing Contracts

Each hospital that participates in the Medicare program is
required to meet specific staffing requirements. This applies to all services
that the hospital furnishes – whether the staff member providing the service is
employed by the hospital, through an arrangement with a co-located hospital, or
under contract with another entity. The draft guidance states that certain
providers who offer services in both co-located facilities, such as nurses, are
prohibited from doing so concurrently. Those staff members can only work for
one health care entity during a shift and are not allowed to “float” between
the co-located facilities.

It is vital that each facility’s staffing levels are adequate
and that contracted workers are properly trained in their duties. The draft
guidance goes on to state, however, that governing body approved medical staff
can be shared or “float” between co-located hospitals if they are privileged
and credentialed at each facility. Hospitals and health care entities could
assume that this ambiguous language refers to physicians, physician assistants,
nurse practitioners, and other similarly trained medical staff. I believe it is
imperative that the final guidance identify the specific medical personnel allowed
to “float”. Many rural and frontier hospitals and providers may, out of an
abundance of caution, decline to offer co-located services if they are not
absolutely certain which medical staff are permitted to “float” and which ones
are not.

Emergency Services

The draft guidance contains several policies that outline how
co-located hospitals and health care entities may furnish emergency services. I
would ask CMS to refine and clarify this proposed language in order to reduce
provider confusion. Hospital emergency departments furnish services to
individuals coming to the facility from the community who are experiencing an
urgent medical event. They also provide care to patients admitted to the
hospital who may experience an emergent event. Because an emergency can occur
anywhere in a hospital setting, it is important that the Agency clarify its
terminology in order to reflect policy intent. Doing so will go a long way
toward helping hospitals and other health care entities that want to enter into
co-location and shared space arrangements be better equipped to make informed
compliance decisions.

CMS faces a difficult task to finalize clear co-location
standards that can apply to a wide range of administrative and clinical
situations. I appreciate the agency offering Congress and health care
stakeholders the opportunity to provide constructive policy feedback as we work
toward a mutual goal: appropriate,
practical, and innovative co-location requirements. Upon the issuance of final
guidance, I ask that CMS conduct robust education and outreach not only to
hospitals, hospital systems, and other health care entities, but also to
surveyors. The surveyors must receive in-depth training to ensure accurate and
uniform implementation of the new requirements.

Thank you for your consideration of these comments. Should you
have questions, please contact Erin Dempsey of my Finance Committee staff at
202-224-4515.

Sincerely,

-30-

[1]
United States Department of Health and Human Services, Centers for Medicare and
Medicaid Services, Center for Clinical Standards and Quality/Quality, Safety
& Oversight Group, Draft Policy
Guidance for Hospital Co-Location with Other Hospitals or Healthcare Facilities,
Reference Number QSO-19-13-Hospital, May
3, 2019.